MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Premature End-of-Life Indicator (1480)

Patient Problems Fatigue (1849); Pain (1994); Depression (2361); No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2018

Event Type  malfunction  

Event Description

Patient stated that her vns is nearing ifi (intensive follow up indicator) and suspects premature depletion.

Event Description

Clinic notes were received and indicate that the patient experiences fatigue and mood disturbances that is attributed to low battery of the vns.The physician indicates that the vns is low but is still running.Patient also voiced concerns with deteriorating mood and local pain/discomfort at the implant site.Patient voiced this during the interrogation of the device.

Event Description

Additional programming data was received and analysis of the data shows that the device to be depleting prematurely.The patient underwent generator replacement surgery.The explanted generator has not been received to date.

Event Description

The explanted generator was received for analysis and analysis was completed.The device output signal was monitored for more than 24 hours while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Diagnostics were as expected and the generator performed according to functional specifications.The reported ¿premature depletion¿ was not duplicated, however the battery measured 2.776v showing an intensified follow-up indicator = yes (ifi=yes) condition while data in the generator's stored memory revealed that 71.046% of the battery had been consumed.The ifi=yes condition was determined to be related to an expected event due to the generator remaining "on" post-explant.The electrical performance of the generator concludes that no anomalies exist and the ifi=yes was an expected event.There were no additional performance or any other type of adverse conditions found with the returned generator no additional, relevant information was received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7814745
• MDR Text Key: 118254083
• Report Number: 1644487-2018-01489
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2019
• Device Model Number: 103
• Device Lot Number: 204171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 09/27/2018; 03/20/2019
• Supplement Dates FDA Received: 09/21/2018; 10/23/2018; 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR